The change to the formulation of the Covid vaccine signals the beginning of the FDA’s pivot in immunization strategy

Recent evidence indicates that current bivalents provide protection against severe disease and death from the XBB.1 variant that is currently prevalent in the United States.

“We’ve turned the corner from a pandemic phase to an endemic phase,” said Ofer Levy, a staff physician at Boston Children’s Hospital, a professor at Harvard Medical School and a member of the Food and Drug Administration committee. “Today’s vote marks a huge practical win for the American people.”

According to the CDC, approximately 69 percent of adults living in the United States have completed their primary vaccination series. More than 80 percent have received at least one injection, but 20 percent are still not fully immunized. Only about 15 percent of Americans, or 50 million people, have received bivalent boosters to date.

Advisers stressed that this modernization would simplify vaccination operations in the future, which could lead to more vaccinations.

“I think anything that results in better public communication, to get more unvaccinated vaccines is going to be very valuable,” said Henry Bernstein, MD, a professor of pediatrics at Hofstra University and a member of the advisory committee.

The recommendation still needs to be approved by the Food and Drug Administration and the CDC before all vaccines are updated. Although the FDA does not have to agree with its advisory committee, it often does.

“We believe that simplifying the vaccination system will contribute to easier vaccine deployment, better communication, and better vaccine coverage,” said Jerry Ware, director of the division of viral products in the FDA’s Office of Vaccine Research and Review.

The update will affect children’s vaccines, including those for children 5 years of age and younger. Vaccination rates among the youngest children are the lowest of all demographics. Only 5.3 percent of children ages 2 to 4 and 3.5 percent of children ages six months to two years completed the full series of vaccinations.

For children under 2, the agency hopes to see more data on the bivalent vaccine, said Peter Marks, director of the FDA’s Center for Biologicals Evaluation and Research. “The reassuring thing…is that the safety profile we saw with bivalent boosters well reflects the original vaccine in this age group,” he said.

In addition to the committee’s recommendation, advisors focused their discussion on Thursday on the best way forward for COVID immunization strategies.

One such strategy is to update the vaccine annually based on the variants that are most prevalent and distributed annually, similar to the influenza vaccine. Given the fact that the vast majority of people in the United States have already been exposed to Covid-19, it’s likely that previously vaccinated healthy adults and teens will need one dose per year, while younger children, the elderly, or those with compromised immune systems may need it. Weak to two doses.

Advisers cautioned that a direct reversal of influenza vaccination schedules may not work for Covid, although they understood the desire to roll out an easy-to-implement schedule. “We need to … make sure that we don’t just follow dogma,” said Bruce Gillen, chair of global public health strategy at the Rockefeller Foundation and a member of the advisory committee.

They concluded that more data is needed before a decision can be made on a concrete vaccination strategy going forward. To answer this question of how often, combined with immunogenicity and efficacy data, [we need] said Hayley Gans, MD, professor of pediatrics at Stanford University Medical Center.

However, the US Food and Drug Administration has stressed its desire to simplify the vaccination process to encourage those who have not been vaccinated to get vaccinated. “We heard loud and clear that we need to use a data-driven approach to come up with the simplest possible scheme that enables us to vaccinate,” Marks said. “It should be as simple as possible, but not oversimplified, as they say about Mozart’s music.”

The advisors also looked at how manufacturers could align any updates to their Covid-19 shots so that they are based on the same variant. Currently, only the Pfizer-BioNTech and Moderna shots have been updated to induce immunity against the Omicron subtype BA.4 and BA.5 variants. The data indicates that these shots also produce immunity against the XBB.1 strain of the virus, which is currently the most common virus. The Novavax vaccine, which is licensed as a primary series and booster for adults, has not yet been updated.

“We believe we are an important tool for promotion, and [for] said Philip Dubovsky, executive vice president and chief medical officer of Novavax. Dubovsky said the company will look to the agency’s recommendation on alternative selection for future shots.

Novavax provided data showing that its baseline vaccine provided adequate protection against BA.4/5 variants, unlike mRNA shots that required an earlier update. But he noted that immunity to variants such as XBB.1 has diminished, indicating that it is time for an update.

“The mRNA was amazing,” said Pamela McInnes, deputy director of the National Center for Translational Science Development at the National Institutes of Health and a voting member. “But it may not give us that breadth of coverage, which is really what I think our problem is at the moment.”

Some advisers felt it was still too early to say whether managing Covid-19 moving forward would require annual visits. “We may or may not need an annual vaccine,” said Cody Meisner, MD, a pediatrician at Tufts Children’s Hospital. “It seems to me that it is too early in the process.”

“I don’t think we set it in stone and we’ll see how it goes. We may need to adapt along the way. But overall, I think this is a good path.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top